K-number	K160797
Device name	FMX314 Surgical Platform
Applicant	Fortimedix Surgical B.V.
Product code	OTJ
Device class	Class II
Decision date	Aug 26, 2016
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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FMX314 Surgical Platform

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